A Phase 2, Multicenter, Randomized, Double-blind, Placebo‑controlled Study with Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ‑73763989 + Nucleos(t)ide Analog in Participants Co‑infected with Hepatitis B and Hepatitis D Virus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506763-33-00

Enrollment

Registered

2024-02-08

Start date

2020-12-18

Completion date

2025-01-15

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B and Hepatitis D Viral Co-infection

Brief summary

Proportion of participants with HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT levels at Week 48.

Interventions

DRUGTENOFOVIR ALAFENAMIDE

DRUGSodium chloride solution 0.9%

DRUGENTECAVIR

DRUGTENOFOVIR DISOPROXIL

DRUGJNJ-73763989

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Proportion of participants with HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT levels at Week 48.	—

Countries

France, Italy, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026